TopCare Pain Relieving Roll-On

Product NDC: 36800-290
11-digit product format: 368000290
Labeler code: 36800
Product ID: 36800-290_d6e69347-6255-4460-97e1-754359314327
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL, UNSPECIFIED FORM
Dosage form: GEL
Route: TOPICAL
Labeler: Topco Associates LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-09-03
Substance: MENTHOL, UNSPECIFIED FORM
Active strength: 40 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36800-290-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36800-290-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36800-290-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	36800-290-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	36800-290-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	36800-290-01	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: TopCare Pain Relieving Roll-On
Brand name suffix: Topical Analgesic
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
415974	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
48589893-ca67-471d-88bc-92014295ab9f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
36800-290-01	2024-11-13	C162847	48780-1	f386c64a-2164-0266-e053-dadaa90a7c1a	TopCare Pain Relieving Roll-On Gel Topical Analgesic
36800-290-01	2023-01-30	C162847	48780-1	f386c64a-2164-0266-e053-dadaa90a7c1a	TopCare Pain Relieving Roll-On Gel Topical Analgesic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-290-01	TopCare Pain Relieving Roll-OnTopical Analgesic	74 mL in 1 BOTTLE, WITH APPLICATOR	GEL	74		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-290	TOPCARE PAIN RELIEVING ROLL-ON TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM) GEL [TOPCO ASSOCIATES LLC]	3	Current NDC, Legacy NDC, 1 package rows	20241115_48589893-ca67-471d-88bc-92014295ab9f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 84 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SYNC ICE	SYNC RELIEF ICE	iON Pharma, LLC	38ce98ce-a7bf-8041-e063-6394a90ae730	2025-07-28	Warnings	Exact identifier application number: M017
SYNC PRO	SYNC RELIEF PRO CREAM	iON Pharma, LLC	3a3e91d6-732b-dca9-e063-6394a90a06d4	2025-07-28	Warnings	Exact identifier application number: M017
Careland Pain Relief	METHYL SALICYLATE, MENTHOL	Planet (Anhui) Pharmaceutical Co., Ltd.	83f36771-1033-4fd0-a0e6-82c1dcfedeee	2025-07-28	Warnings	Exact identifier application number: M017
Rite Aid anti-itch	HYDROCORTISONE	Rite Aid Corporation	2a232dd1-9071-4c55-a7f7-19d8404b99a6	2025-07-28	Warnings	Exact identifier application number: M017
Hydrocortisone Plus 12 Moisturizers	HYDROCORTISONE	RITE AID CORPORATION	05598255-3e7a-46a5-ae7e-dcfcb616d59d	2025-07-28	Warnings	Exact identifier application number: M017
Inked Inspired	LIDOCAINE HCL	Prodigy Media Inc	54fb2860-7e63-4598-953a-170226e613e9	2025-07-28	Warnings	Exact identifier application number: M017
Ujhay Hydrocortisone Ointment.	UJHAY HYDROCORTISONE OINTMENT	Guangdong Quadrant Ecological Technology Co., Ltd.	3af59276-8e6a-0603-e063-6394a90a1f9b	2025-07-27	Warnings	Exact identifier application number: M017
SANA SANA Menthol External Analgesic	MENTHOL	Alquimia Najulam S de RL de CV	8b7edd51-e08a-4e01-9df0-8305ce17b418	2025-07-25	Warnings	Exact identifier application number: M017
Hydrocortisone Intensive Healing Formula	HYDROCORTISONE	TARGET Corporation	682b737f-e453-4079-bf31-47a9485c7897	2025-07-25	Warnings	Exact identifier application number: M017
Chigg Away	BENZOCAINE	Pierson Laboratories, Inc.	8372e7c1-f145-4bc5-85ab-cf831abe70ce	2025-07-24	Warnings	Exact identifier application number: M017
Chigg Away	BENZOCAINE	Pharma Nobis, LLC	e42fa1c6-d804-630f-e053-2995a90add6b	2025-07-24	Warnings	Exact identifier application number: M017
Cannarelief 2000mg	MENTHOL	Earthmed LLC	01f810de-52ba-8beb-e063-6394a90a61c0	2025-07-24	Warnings	Exact identifier application number: M017
CHING WAN HUNG SOOTHING HERBAL BALM	MENTHOL	TIANJIN DARENTANG JINGWANHONG PHARMACEUTICAL CO., LTD.	ffadc904-8e9d-4cb8-815a-d583bbdb3f0b	2025-07-24	Warnings	Exact identifier application number: M017
PT Elite Premium Pain Relief	CAPSAICIN, MENTHOL	PT ELITE PRODUCTS LLC	ad251821-4c58-425d-bdcb-8dd9bd41b713	2025-07-23	Warnings	Exact identifier application number: M017
Whipped Butter SPF 50	ZINC OXIDE	Bloomeffects, Inc	374b62d8-e012-591f-e063-6294a90aef93	2025-07-23	Warnings	Exact identifier application number: M017
Game On Xtreme	MENTHOL, UNSPECIFIED FORM	Natural Essentials Inc.	5a1b6192-d537-42b3-add8-22c63e7c986c	2025-07-23	Warnings	Exact identifier application number: M017
AMRUTANJAN RELIEF PAIN BALM	CAMPHOR , MENTHOL, METHYL SALICYLATE	AMRUTANJAN HEALTH CARE LIMITED	ddee6714-8b18-4d87-944b-8467fda22e6b	2025-07-23	Warnings	Exact identifier application number: M017
Stopain Extra Strength Gel	MENTHOL	Troy Manufacturing, Inc.	8bb89002-d7a2-4bee-b5a5-1fd1949273ef	2025-07-22	Warnings	Exact identifier application number: M017
Hielo Ardiente	MENTHOL	Menper Distributors, Inc.	97ec516c-d2bc-47ce-82fe-bd68445d9570	2025-07-22	Warnings	Exact identifier application number: M017
La Flecha Japonesa	METHYL SALICYLATE	Menper Distributors, Inc.	08819ad0-97c2-49bd-b923-535b94a27167	2025-07-22	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
415974	menthol 4 % Topical Gel	PSN	48589893-ca67-471d-88bc-92014295ab9f	4
415974	menthol 0.04 MG/MG Topical Gel	SCD	48589893-ca67-471d-88bc-92014295ab9f	4
415974	menthol 4 % Topical Gel	SY	48589893-ca67-471d-88bc-92014295ab9f	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-290-01	36800029001	74 mL in 1 BOTTLE, WITH APPLICATOR (36800-290-01)	74 ml	2020-09-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TopCare Pain Relieving Roll-On Gel Topical Analgesic	Topco Associates LLC \| Garcoa, Inc. \| SV Labs Toronto Corporation	2024-11-13	HUMAN OTC DRUG LABEL	4